eSTAR Now Open For PMA Submissions
The US FDA electronic submission process for streamlining its product review process is now available for sponsors submitting some premarket approval applications.
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Nine device makers will soon have the chance to enroll in a voluntary eSTAR pilot program that the US agency says will make the premarket review process more efficient and consistent. The design and structure of an electronic Submission Template And Resource – or eSTAR – template is similar to templates used by FDA reviewers. An eSTAR won’t change the agency’s statutory or data requirements for sponsors to show substantial equivalence to predicate devices.